UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023474
Receipt No. R000020576
Scientific Title A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery
Date of disclosure of the study information 2016/08/04
Last modified on 2020/05/10 (Ver. 5)

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Basic information
Public title A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery
Acronym Comparison of paravertebral vs intercostal nerve blockade for VATS thoracic surgery
Scientific Title A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery
Scientific Title:Acronym Comparison of paravertebral vs intercostal nerve blockade for VATS thoracic surgery
Region
Japan

Condition
Condition Lung tumor
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness of PVB and intercostal nerve block after VATS lobectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scale after operation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Paravertebral block catheter was inserted by the srugeon under direct vision before chest closure
Interventions/Control_2 Intercostal block catheter was inserted by the srugeon under direct vision before chest closure
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria ASA PS one, two and three
Aged from twenty to eighty five
Obtaning informed patient consent
VATS lobectomy including left segmentectomy
Key exclusion criteria Past history of same side thoracotomy
Risk of pleural adhesion
Past history of radiotherapy
Allergy to local anaesthetics or opioid
A woman who is pregnant, or may be pregnant
Sepsis
infection of puncuture skin
Having mental troubles
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shoichi
Middle name
Last name Mori
Organization Japanese Red Cross Nagoya Daiichi Hospital
Division name Department of Thoracic Surgery
Zip code 453-0046
Address Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL 0524815111
Email smori@nagoya-1st.jrc.or.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Kadomatsu
Organization Japanese Red Cross Nagoya Daiichi Hospital
Division name Department of Thoracic Surgery
Zip code 453-0046
Address Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL 0524815111
Homepage URL
Email yuka.kadomatsu@gmail.com

Sponsor
Institute Japanese Red Cross Nagoya Daiishi Hospital
Institute
Department

Funding Source
Organization No funding source
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Red Cross Nagoya Daiichi Hospital
Address Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
Tel 052-485-1121
Email yoko@nagoya-1st.jrc.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 04 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s11748-018-0936-8
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s11748-018-0936-8
Number of participants that the trial has enrolled 50
Results 
Our results could not clearly establish noninferiority of ICB to PVB. Improvements in ICB may be necessary for it to be used as an alternative method to PVB.
Results date posted
2020 Year 05 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
PVG group: 26 cases, ICT group: 24 cases
There were no significant differences in the characteristics between the two groups except for laterality.
Participant flow 
Preoperative random allocation to PVB or ICT group.
Adverse events 
None
Outcome measures 
Postoperative pain
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 06 Month 19 Day
Date of IRB
2015 Year 05 Month 03 Day
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2018 Year 02 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020576